OpenIDEO is an open innovation platform. Join our global community to solve big challenges for social good. Sign up, Login or Learn more

Helping parents keep their drug-exposed baby (and themselves) healthy

We can provide caregivers an award winning product to improve the health and reduce the burden of caring for drug-exposed infants.

Photo of John Konsin
33 23

Written by

Updates: How has your idea changed or evolved throughout the Prize? What updates have you made to this submission? (1500 characters)

While I've learned many things throughout the Prize process, two new learnings stand out above the rest. New learning #1 - there is a growing understanding, urgency and concern in every State with drug-exposed infants. Previous to the Prize, my belief was that some States were indifferent to the issue of drug-exposed newborns. New learning #2 - before the Prize we looked at helping infants diagnosed with neonatal abstinence syndrome during withdrawal and after withdrawal. We now realize that our product may be able to minimize the symptoms in drug-exposed newborns so much that infants could avoid be diagnosed with NAS. Why is this important? Most infants born with a drug-exposure are born in rural hospitals. NAS symptoms don't present themselves till a few days after birth. Once symptoms are observed and their observational scores go above a threshold - they are diagnosed with NAS. Once diagnosed they are typically sent to a hospital in an urban area with a level III or IV NICU - seperating mother and child. If our product can be used early enough after birth and reduce the scores it means mother and baby have a greater chance of staying together and the thousands of dollars spent caring for the baby in a NICU is saved. So, we are now looking at how we can help drug-exposed infants (and their caregivers) before, during and after withdrawal.

Name or Organization

Prapela LLC

Geography

Our company is in Concord , MA. Our product can help any drug-exposed baby born anywhere.

What is your stage of development?

  • Early Stage Innovator, with at least one-year experience in ECD

Type

  • For-profit

What is the stage of your proposal?

  • Piloting: I have started to implement my solution as a whole with a first set of real users.

Describe how your solution could be a game-changer for your selected Opportunity Area (600 characters)

Our award winning, "Next-Gen Baby Box" with its gentle, stochastic vibrating sleeping pad improves the withdrawal and post-withdrawal experience for drug-exposed newborns and their mothers. Used in the hospital to treat infant drug withdrawal symptoms, our baby box helps relax newborns as it improves the rhythmicity of heart and lungs. Used after discharge from the hospital, the Prapela SVS baby box makes it easier for caregivers to console infants, helping baby and everyone else at home get the sleep they need to stay healthy.

Select an Innovation Target

  • Product: A new or enhanced physical product that creates value for end beneficiaries.

Tell us more about your innovation (1500 characters)

The gentle, stochastic vibration from the Prapela SVS baby box stimulates nerves and as the brain processes the signals, pacemaker neurons enhance the rhythmicity of the lungs and heart increasing relaxation and improving cardiorespiratory function crucial for healthy infant development. This is no ordinary vibration. It’s precise displacement is controlled by 2 micro processors and proprietary firmware developed over 7 years at the Wyss Institute.
There have been 4 studies on SVS, the most recent independent study on infants diagnosed with neonatal abstinence syndrome (NAS) published in April reported a 35% improvement in relaxation along with statistically significant improvement in respiratory rate and cardiac intervals. And there is an on-going study funded by the NIH examining the cognitive and behavioral benefits of SVS with drug-exposed infants. The technology is covered by an issued patent with another 4 submitted and under review. Most recently, on February 7th 2018, the NIH awarded Prapela a grant supporting its efforts to improve the care and reduce the cost to treat infants with NAS.

What problem are you aiming to solve? (3 sentences)

Our substance abuse epidemic is tragically impacting our newborns and mostly poor families. Called neonatal abstinence syndrome - newborns suffer from irritability, tremors, respiratory distress and struggle to sleep. This year 50,000 NAS infants will be treated at a cost of more than $3 billion – straining caregivers in hospitals and at home. This situation indicates the need for a clinically proven, drug-free product to treat and support of drug-exposed infants & caregivers.

Explain your idea (5000 characters)

Our plan is to provide affordable, clinically proven, medical and consumer products that improve infant health based on our core competency in stochastic vibro-tactile stimulation (SVS). Thus far, in clinical evaluations, our technology has proven to help infants relax, enhance their cardio-respiratory function and improve oxygenation - all vital to healthy human development. We have the potential to alleviate many infant health issues including; recovery from drug-exposure, apnea of prematurity, colic and even cognitive and behavioral development. And when we say affordable, we mean affordable to every health system and community wellness program in the World. At Prapela, we think big and believe we have the opportunity to impact the health and wellness of every child.

Our first product is a baby box including a sleeping surface inserted inside the bottom of the box with controls integrated into a power cord that extends outside the box. The box ships flat and pops up to be about 27" long, 17" wide and 10" high. The box is constructed of corrugated cardboard. The sealed platform inserted inside the bottom of the box contains a vibrating actuator and uses extremely low power. A foam mattress covered with both a waterproof liner and a natural cotton fitted sheet sits on top of the platform. A small hole in the box below the platform accommodates the pass through for the power cord. The vibration is turned on for a cycle of treatment by depressing a button - much like a heating pad switch. Set up takes about a minute and with one setting the product is easy to learn and use.

While treating NAS infants during withdrawal our baby box would be used as a complementary relaxation/sleeping site in the hospital nursery as well as in-room with mother. Whenever caregivers are unable to hold or cuddle a NAS infant, the patient would be placed in the baby box and the switch turned on to activate the SVS platform. After discharge from the hospital, the baby box would be used at home either as the primary sleeping environment or supplemental site for both daytime naps and evening sleep. The SVS baby box easily fits inside a bassinet or playpen. Again, whenever a caregiver at home is unable to console an infant by touch, swaddling, skin to skin contact or rocking, the baby would be placed in the box and the switch turned on to help console the infant. A second touch of the button will shut off the vibration cycle. To start the cycle again, the caregiver touches the same button. A dim LED on the control switch will confirm the vibration is active. When the LED light is off, so is the vibration.

For commercialization, we have already identified and started the product development process with our US based contract manufacturing partners and we will bill and ship from a central site in New England. Our unique, foldable box will be made by an established box manufacturer. Our electronics package will be assembled and tested by an electronic manufacturing services company in operation for almost 40 years. We will be proud to say our product will be made in America.

Priced at approximately $150 each, we will position the product to help reduce stay, reduce morphine use and improve care after discharge. For hospitals that prefer not to provide the product at discharge, the same product will be available online at our eCommerce website at $150 with two-day delivery.

NAS is a concentrated market which makes it easy and affordable to reach. Neonatologists and Neonatal Nurse Practitioners are the most active health care practitioners and regularly attend a few national organization meetings/conferences. Special meetings on NAS held by State agencies and professional medical organizations are well promoted and attended. Our plan is to cover the market with a small number of neonatal specialists and an informative and efficient e-commerce website. Further, through social media we plan to educate the community on the benefits and affordability of our product, encouraging them to evaluate and purchase the product.

Our goal is that within 2 years after launch, we expect more than 50% of the drug-exposed newborns and their caregivers will use the product - improving their overall health and giving them a better chance at a lifetime of wellness

Who benefits? (1500 characters)

50,000+ drug exposed newborns each year - by improving their health & wellness

The parents/caregivers of drug-exposed newborns - reducing their stress and workload of care.

Social workers who help support new parents recovering from addiction while caring for their NAS baby.

The community where our drug-exposed babies are raised - with better health these kids will be free to help their communities be stronger/better as they grow into adulthood.

Medicaid - with a non-pharmacological tool that improves care and lowers the cost to take care of the 80% or more of drug-exposed babies covered under Medicare.

US Citizens - by reducing the amount we spend to care for NAS infants (>$60,000 each) while improving outcomes

When parents and caregivers experience how our technology consoles their baby they sometimes begin to cry. Often its the first time they have seen their baby relaxed, making eye contact or not screaming. The impact of our product is often deeply emotional.

What kind of impact will your idea have? (1500 characters)

Over 10 ago, the CHIME studies found that 62% of even healthy infants experience intermittent breathing and low oxygenation levels. Some researchers suspect that, depending on the frequency and severity, these episodes may negativey impact a child's health & development. Our product reduces the frequency and severity of these episodes. So, we could possibly have a systemic positive impact on the development of every child. While it will take years to prove/disprove some long-term benefits of SVS technology, we can help kids with drug-exposure right now!

The Protecting our Infants Act law, tasks the HHS to develop the strategy and treatment for NAS. On 10/4/17, the GAO cited the HHS for falling behind and recommended to “prioritize non-pharmacological approaches to treat NAS and to provide resources for an infant after discharge." Working with HHS and Medicaid (which reports to HHS) we can provide a drug-free solution for pre & post withdrawal care of NAS infants.

In their April 2017 report on "Heroin in Colorado", the Colorado Department of Public Health and Environment reported an 83% increase in NAS cases among Colorado infants from 2010 to 2015. Many believe the incidence of NAS is still under reported as many hospitals do not correctly identify NAS with the new reporting ICD-10 codes. Working with the State, Prapela can help reduce the incidence, improve treatment and reduce the cost to treat NAS.

How does or how could your idea impact low-income children? (1500 characters)

According to the October, 2017 US Government Accountability Office (GAO) report on NAS to Congress, 80% or more of drug-exposed infants are on Medicaid due to their families low-income level.

Our product helps relieve withdrawal and post-withdrawal symptoms drug-exposed newborns experience after birth and helps caregivers get the rest they need. Additionally, the Prapela SVS baby box may become useful in reducing the number of infants diagnosed with NAS. As a 'first response" non-pharmacological treatment for suspected drug-exposed infants, it could prove to console infants so effectively that a NAS diagnosis is prevented. This would result in fewer drug-exposed newborns treated with costly and riskier morphine or buprenorphine for withdrawal.

Innovation: What makes your concept innovative? (5000 characters)

The Prapela SVS baby box is innovative by providing a solution to a large, growing, expressed and unfulfilled need - a cost effective treatment for drug-exposed infants.

Specifically, Prapela's SVS baby box has the potential to become a key part of a new standard of treatment of drug-exposed infants. Today, there is no accepeted standard of care for NAS infants and the US Department of Health & Human Services, State and Local healthcare agencies are looking for a solution.

As the only non-pharmacological product proven to console and improves cardiorespiratory function in NAS infants, with additional evaluations we believe health care practitioners will adopt its use for; 1) treating infants before a NAS diagnosis, 2) support during withdrawal and 3) to assist caregivers at home after withdrawal.

Scale: Describe how your idea could reach a significant number of end-users. (1500 characters)

We have several tactics planned to reach a siginficant number of end-users. 1) We plan to reach out to each of the State programs funded by the programs supported by the Maternal and Child Health Bureau of the US Health Resources & Services Administration/HHS. 2) We are in discussions with the largest on-line nursing community (650,000 members) in the U.S. to provide on-line education on NAS and our product. 3) Additionally, the community of professional caregivers focused on NAS infants is relatively small, making it affordable and easy to reach. In the US there are less than 1,000 sites with neonatal intensive care units and approximately 5,000 neonatologists. A majority of sites treating NAS infants are Level III and Level IV NICUS which number less than 300. Thanks to improved tracking and reporting, we know which States have the highest incidence of NAS patients. Targeting our efforts will provide us faster uptake and provide the references we need to help other locations. 4) We will attend major medical meetings on NAS - presenting our technology and 4) through, our eCommerce platform, with free 2 day delivery we will distribute our easy to ship, easy to set up and easy to learn product nationwide at an affordable price.

Feasibility: Where are you with understanding the feasibility of your idea? Describe what you’ve done so far and your plans. (3000 characters)

Two (2) peer-review studies have documented the benefits of SVS with NAS infants

One (1) current study is examining its long-term benefits on the cognitive and behavioral development of NAS infants

We have been recognized by the #1 & #2 ranked "Best Hospitals for Pediatric Neonatology", Children's National Medical Center (Washington DC) and Boston Children's Hospital for Innovation in Pediatric Devices.

On 2/8/18, Prapela was honored to be selected as an award winner in our National Institutes of Health (NIH) “Start a SUD Startup” Challenge. As an award winner, we will benefit from the support provided by the National Institute on Drug Abuse (NIDA) with their initiative to better to further an understanding of neurobiology as it relates to substance use disorders. The award provides a $10,000 grant and connectivity with the National Institute on Drug Abuse.

On 11/30/17, Prapela took top honors in the "Next-Gen Baby Box QuickFire Challenge".
The Prapela(tm) SVS Baby Box was selected over 135 entries from 17 different countries as a leading innovation to promote child health and facilitate healthy parenting. Prapela receives some funding as well as support from Johnson & Johnson, Janssen, the Finnish Innovation Fund - Sitra, Tekes - the Finnish Funding Agency for Innovation and VTT Technical Research Centre of Finland. We are humbled to be selected as a winner in the country that made the Baby Box famous for helping infants sleep safe.

We are preparing our pre-submission for the FDA to review in Q1, 2018

We have identified our key suppliers and with funding begin product safety testing and then our pilot build in Q1 of 2018. We will be evaluating 2nd gen working prototypes in February. Plus over the next 2 months we will be getting user feedback on our set up instructions as well as our switch to turn the product on and off.

With a successful pilot build and clear regulatory path we plan to be on the market by Q2, 2018.

Business Viability: How viable is your business model? (5000 characters)

In terms of product acceptance, during 2017 we completed a survey with approximately 100 parents to test our product's value proposition ( value proposition = primary benefit, to what target customer and price). The survey results indicated broad a large number of parents would likely purchase the product at our target price. However, until the product is made available we will not understand exactly the types of parents and how many will become customers.

To identify the risk in our business model, we developed a five-year plan with over 2,000 documented assumptions that generates our financials by month for 60 months. Additionally, we have competed a SWOT (Strengths, Weaknesses, Opportunities & Threats) analysis and identified potential solutions and programs to mitigate business risk. Further, our operational plan for the company includes quarterly operational reviews to identify and address issues and risks that may prevent the company from reaching its objectives. Based on an evaluation of the market opportunity and our solution combined with our mangement experience, we believe we have the knowledge, skills and abilities to succesfully manage the company through unforseen risks.

HCD: How have you used human centered design to build or refine your concept? (5000 characters)

We have completed surveys with parents, spoken to neonatologists, pediatricians and researchers about our product. As we complete our next working prototype we plan to meet and ask health care practitioners for input on product set-up and operation. What we are most excited about is how individuals react to our product's simplicity. Out of the shipping container, the product can be ready for use in one minute or less. Control of the unit is achieved by pressing the only button on the only control panel provided. With the button pushed, a light is activated on the panel and the stimulation begins. Another touch of the same button turns off the stimulation and the light on the panel. A new user (in testing) "learns" how to use the product in less than a minute. For busy healthcare practitioners, who have little time to stop and learn how to operate a product - ours is easy to learn and easy to use.

Tell us more about you (3000 characters)

Last year, while I was consulting for Harvard's Wyss Institute, a member of my family overdosed on Heroin. I've found life for a recovering addict and family was difficult. However, I couldn't imagine how much more difficult it would be for a recovering addict with a newborn exposed to drugs.

About a month after the overdose, the principals at Harvard's Wyss Institute asked me to evaluate and recommend how to commercialize the SVS technology they had spent 7 years to develop. At the time, faculty at the Wyss were mostly interested in its use for apnea in premature infants. I recommended instead to initially focus on helping drug exposed infants. Then late this past Summer, I came up with the idea to put SVS into an affordable baby box so it could be used in the hospital and then taken home. In September we presented our idea to Childrens National Medical Center and they awarded us $25,000 to help. I'm excited to leverage my University of Colorado MBA and 35 years in medical devices to help address our opioid epidemic.

That's just my side of the story.

The inventor of SVS for infant health, Dr. David Paydarfar, has his own story which begins with his discovery and the challenge of helping preemies with apnea of prematurity.

The SVS product developer, Jim Niemi, has his story which revolves around a desire to develop an affordable stochastic resonance technolgy to help babies breathe, senior citizens keep their balance and to help the disabled improve proprioception and recovery. He's been at it the past ten years of his life.

Then there is Liz Salisbury, PhD, who had the inspiration to explore the use of SVS to help drug-exposed infants more than five years ago and well before we understood the magnitude and the pain of neonatal abstinence syndrome. Her research is independent.

Finally, there is my wife, who agreed to sell off some of our assetts so that we could use the proceeds to finance this endeavor to help kids everywhere.

Do you have the people and partners you need to do what you’ve described? (600 characters)

Yes.

As you consider your next steps, what kinds of help could you use? Is there a type of expertise that would be most helpful? (1800 characters)

Support and feedback from more pediatricians and neonatologists
Community infant sleep education expertise.

Would you like mentoring support?

  • Yes

If so, what type of mentoring support do you think you need? (1200 characters)

I would benefit from having anyone with intelligence, desire and passion for what we are doing to jump in and give advice on any topic. One of the things I learned over the past years is that you can never have enough good people or good ideas. Diversity makes every team better.

Are you willing to share your email contact information submitted on OpenIDEO with Gary Community Investments?

  • Yes, share my contact information

[Optional] Biography: Upload your biography. Please include links to relevant information (portfolio, LinkedIn profile, organization website, etc).

https://www.linkedin.com/in/jkonsin/

www.prapela.com

https://twitter.com/Prapelainfo

https://www.facebook.com/Prapelainfo/

Mentorship: How was your idea supported? (5000 characters)

My mentor - Jessie - was fantastic. While we did not change anything about our product concept, she did provide great insight into other organizations that would have an interest in our solution. She also provided an explanation on how best to reach out and interact with these organizations. We're really grateful for her help and insights and can't wait to reach out to these "new to us" organizations.

What is your stage of development?

  • Early Stage Innovator, with at least one-year experience in ECD

Type

  • For - Profit

What is the stage of your proposal?

  • Piloting: I have started to implement my solution as a whole with a first set of real users.
View more

Attachments (2)

Prapela_OpenIDEO2018.pdf

Quick summary on Prapela - our solution, approach and team

SVS benefits opioid-exposed newborns_2017.pdf

This independent study on our technology documents its benefits with drug-exposed newborns.

33 comments

Join the conversation:

Comment
Photo of Nicola Doherty
Team

I love this concept! Excellent idea! Good luck!

Photo of John Konsin
Team

Nicola, Thank you so much. We've been learning so much through this Challenge and in discussions with physicians, nurses and at home caregivers of drug-exposed infants.

This week I visited with Dr. Michelle Bode at Crouse Hospital in Syracuse, New York. She has been dedicated to helping NAS infants and their caregivers for several years. Dr. Bode reinforced how important it is to collect insights from parents and caregivers on our product. She also discussed how she embraces use of several different approaches to care for drug-exposed infants. At Prapela, we embrace the idea that we will provide one of many helpful tools caregivers can use to better care for our kids. What an inspiration meeting Dr. Bode!

Later today we'll be speaking with Dr. Jennifer McAllister of Cincinnati Children's Hospital Medical Center who recently published a study identifying one of the long-term consequences of NAS infants. We have so much still to learn and Cincinnati Children's is taking a leading role identifying the long-term cosnequences of in utero drug-exposure.

Nicola, it's comments, suggestions and feedback like yours that increases our energy and excitement. Thanks so much for taking the time to review our submission and making a comment. Sincerely, John

Photo of Peggy Sissel, Ed.D.
Team

Hi John, I'll admit that I had to consult with my neuroscientist husband about how this concept worked - and in doing so, we both thought it was amazing. Good luck with it!

Photo of John Konsin
Team

Peggy, Thanks so much. I am so glad you questioned how and why our technology works. Myself, I've learned a lot from Dr. Paydarfar and Jim Niemi (both co-founders) this past year about stochastic resonance technology. Our stochastic vibro-tactile technology (SVS) is one of many different forms of SR (for example SR benefits can be produced with sound instead of gentle vibration). It is a field of science that has been percolating for the past 20 years. Based on the work at UMass, Harvard and other organizations - I'm pretty confident other "SR" products will be introduced in many other applications. One example is improving balance in the elderly.

To help our "story", I'm also excited to share that last night the National Institutes of Health selected Prapela as a winner in its Substance Use Disorder Challenge. We are humbled to have the NIH support our initiative. I'll be posting the news on our application and on social media later today.

Again, thanks so much for your interest and taking the time to comment.

Photo of Peggy Sissel, Ed.D.
Team

Congratulations! That is wonderful news. Thanks for sharing - I love connecting with amazing people and projects!

Photo of geoffrey mosigisi
Team

Greetings, John konsin


I welcome you, I wish to receive your feedback on my idea #helpmegadget.thanks

Photo of John Konsin
Team

Geoffrey, I'll give it a look today. Thanks for asking!

Photo of Karl Kuzis
Team

John,
Congratulations on having the insight and drive to develop an affordable and studied product to assist the next generations through our country’s opiate epidemic.

As a Family Physician with an interest in rural issues, I would like to impress upon you the additional value that Prapela’s SVS system may provide in rural communities.

As you likely are aware, the opiate crisis has a geographical component to it. Good documentation of this can be seen in the 2016 JAMA Pediatrics article by Villapiano et al. In their article, the authors reviewed national data and found that pre-natal maternal opiate use in rural counties (recorded at time of delivery) occurred at a much greater rate, 8 cases per 1,000 as opposed to 4.8 per 1,000 childbirth hospitalizations in urban counties. So while rural infants accounted for “only” 21 percent of all infants with NAS, the burden of treating these infants in rural communities is disproportionately higher than in urban settings (2012 data).

While great progress has been made in making Neonatal Intensive Care Unit (NICU) treatment available across the United States, the logistics and costs of delivering this high level of care make it unobtainable in many rural communities, due in part to the generally lower economic status of rural areas.

Prapela’s “Next-Gen Baby Box” has the opportunity to provide a cost effective, non-pharmaceutical, widely available, research supported method of helping not only the newborn’s physiology but the family’s stability and success by helping to promote good quality sleep.

Some of our youngest patients & their families are sure to benefit from your efforts.

Best of luck with continued development!

Respectfully, Karl Kuzis MD PhD

Journal Reference:
Nicole L. G. Villapiano, Tyler N. A. Winkelman, Katy B. Kozhimannil, Matthew M. Davis, Stephen W. Patrick. Rural and Urban Differences in Neonatal Abstinence Syndrome and Maternal Opioid Use, 2004 to 2013. JAMA Pediatrics, 2016; DOI: 10.1001/jamapediatrics.2016.3750

Photo of Mike
Team

John,
Job well done getting the word out on Prapela's new product for infant health. I know this technology has been well documented through the WYSS Institute and Harvard Medical. Anything that can help NAS and pre-mature infants is extremely important. Good luck . Best Mike Wing

Photo of Iliriana Kacaniku
Team

Hey John Konsin ,
Few days ago we shared with you the invitation to the two webinars in which you will have a chance to hear more about the Prize and ask any questions about the process. I think this is a great opportunity to hear more about the challenge and ask any questions you may have on how to develop your idea along this goal. And many other aspects of the Prize and human-centered design.

We’ll be hosting calls on
Tuesday, December 5, 4:30 - 5:30 PM PST (https://ideo.zoom.us/webinar/register/WN_ZxbEbA4rRPid02QEos1VtQ) and

Wednesday, December 6, 08:00 - 9:00 AM PST (https://ideo.zoom.us/webinar/register/WN_8ZHf8DakS4WWqAXsN_jhQQ).

In case you cant make it, feel free to email us any question you may have at ecprize@ideo.com!, and we’ll do our best to answer it during the webinar.

Looking forward to seeing you next week,
Iliriana

Photo of John Konsin
Team

Iliriana, thank you for the opportunity and the reminder. I look forward to being on the call. In the meantime, thank you for the excellent communication onthe program and most importantly the opportunity to work with others to help our kids.

Photo of Calistus
Team

Dear John, Thank you for this novel innovation geared towards saving innocent kids. It is timely. I also think that we must as a matter of urgency find ways to dissuade women of child bearing age from excessive use of drugs.
-Calistus

Photo of John Konsin
Team

Calistus, thank you so much for your kind words. It is truly an honor to have the opportunity to introduce this gentle stimulation and first of its kind treatment to help our infants and their caregivers.

This past week we were given another boost. We were honored to win a global competition held in Helsinki, Finland - in the country that made the Baby Box world famous. Called the "Next-Gen Baby Box QuickFire Challenge", the Prapela(tm) SVS Baby Box was selected over 135 entries from 17 different countries as a leading innovation to promote child health and facilitate healthy parenting.

As the top prize winner, Prapela receives some funding as well as support from the Johnson & Johnson, Janssen, the Finnish Innovation Fund - Sitra, Tekes - the Finnish Funding Agency for Innovation and VTT Technical Research Centre of Finland. Still, any support we can gain from the OpenIDEO challange is needed. You see, in our efforts to raise funding from private investors we found only minimal interest. The reason being is that many investors prefer "recurring revenue" models. They are attracted to monthly collections for disposables or subscriptions. Which is exactly what parents, caregivers and Medicaid (who pays for 80% of NAS treatments) don't want and can't afford. Our simple product and emphasis on affordable, one-time fee is what, we believe, is part of what we need to help. We are sticking to our approach and will continue to do our best to raise the funding we need from challenges and investors like Gary Community Investments.

So, thank you again. We're excited about this challenge and the potential it has to support our efforts to produce a product to help drug-exposed newborns and their caregivers.

I wish you the best to you, your family and friends. Sincerely - John

Photo of Jim Niemi
Team

John - This non-pharma based approach to NAS (and other conditions) is outstanding, precisely positioned, and extremely timely given the growing incidence. Additionally, this solution is designed for affordability and scalability, making it truly a revolutionary technology that can be deployed anywhere for anyone in need.

Photo of John Konsin
Team

Jim, Thanks for sharing your thoughts. Much appreciated. Sincerely, John

Photo of Michael Wing
Team

John,
Your work on the NAS issue for Infants addresses a significant and growing problem. Using the WYSS Institutes SRV Technology to help baby's relax and more is a brilliant idea. The potential for reducing the need for drug treatment and reducing time in care, will not only help the child, but the parents as well. Best of success moving forward.

Photo of John Konsin
Team

Mike, Thanks for the kind words. The on-going, long-term, independent study will provide even greater insights. That study will be complete in 2021. In the meantime, we'll be working on some short-term studies to understand how we can help reduce length of stay, use of morphine, readmission rates and perhaps even improve mother to infant bonding.

Photo of Tom
Team

John - Excellent, cost effective innovation aimed at a significant social problem involving helpless children. Reducing or eliminating drug therapies only makes the idea stronger in my mind. Keep up the great work and on behalf of those fragile young lives, thank you!

Photo of John Konsin
Team

Tom, Thanks for your encouragement. It only makes sense that we treat drug-exposed infants with a drug-free solution. The independent clinical research on the technology helping NAS/Drug-exposed infants has been really encouraging. Making it affordable so that hospitals can use it and then give away to parents/givers at discharge for use at home is what we want to achieve. We have a great opportunity to help make a difference for these babies and their caregviers (both in the hospital and at home).

Photo of Animesh
Team

John Konsin : I believe that a non-pharmacological method to help children with neonatal abstinence syndrome is a great idea: addressing the physiology directly could help us treat these patients better! Also, I think this technology could have wide applicability to other infants with intense needs. Keep up the good work bringing technological innovation to infants in need!
Animesh Tandon, MD, MS

Photo of John Konsin
Team

Dr. Tandon, Thank you for your comments. It's encouraging to hear of physicians embrace drug-free approaches to improve infant health. For years, so many inventors have been trying to create a vibration that improves infant health. About the only result has been those monotonous vibrations that distract infants. Dr. Paydarfar and Jim Niemi (my fellow co-founders) finally cracked the code developing the first vibration, clinically proven to help infants both relax and breathe. We're really excited about making this discovery available in Colorado, the United States and eventually around the World. Your support and hopefully support from Gary Community Investments with this terrific program will really help us help kids. Thanks!

Photo of Dominic
Team

Dear John:
I listened to your passionate and compelling presentation at the Nov. 7th MATTO (Massachusetts Association of Technology Transfer Offices) New Ventures Showcase; a significant poorly addressed and understood medical need (neonatal abstinence syndrome). Glad to learn about this new technology (SVS) from The Wyss Institute with multiple potential applications. A pleasant surprise that it is cost-effective compared to the current default solutions and heartened to hear that you are manufacturing the product in the USA.
Please let me know if I can support your efforts...
Best wishes on the upcoming competition in Finland!
Sincerely yours,
Dominic Tong, M.D.

Photo of John Konsin
Team

Dr. Tong, Thank you for your comments. We love that Gary Community Investments with its focus on the needs of Colorado's low income children and their families is sponsoring this OPENIDEO challenge.

The following from Rocky Mountain PBS News illustrates what is happening in Colorado with drug-exposed newborns and from national data we know that 80% of all children treated for NAS are covered by Medicaid. So, the conclusion is that drug-exposed newborns are a growing, costly concern to low income families and the State of Colorado. As one of the 6 states giving away conventional baby boxes for free, it would be great to see Colorado getting behind our next gen baby box to help drug-exposed newborns.

The following lifted from 2/10/17 issue of PBS Rocky Mountain News...

"Colorado does not consistently and uniformly track where and how often drug-addicted mothers give birth to babies who suffer from withdrawal symptoms related to opioid use, also known as Neonatal Abstinence Syndrome. However, at the request of Rocky Mountain PBS, the Colorado Hospital Association evaluated five years of medical codes from birth records at the organization’s one hundred hospitals statewide.

According to their data, the number of newborns experiencing opioid-related withdrawal symptoms increased nearly two and a half times between 2011 and 2015."

Photo of KB
Team

John - great work on this project and very timely, the rapid increase in infants with neonatal abstinence syndrome has become one of the most challenging issues in the newborn arena both in the US and increasingly in Europe. An effective and proven non pharma solution for these babies would bring benefits all round, immediate social and financial benefits with probably longer term better outcomes for these babies and their families as they grow up. Well done!

Photo of John Konsin
Team

KB, Thank you. We appreciate your encouragement. We visited Washington DC last week to talk to staffers at the Department of Health & Human Services about NAS. HHS manages the Centers for Medicare/Medicaid Services (CMS) and they recommend non-pharmacological solutions for treating NAS / drug-exposed infants. We explained the clinical results of our technology and hope to see it play an important role in helping infants and their caregivers. Support from this OPENIDEO Challenge would go a long way in helping us and our vulnerable, drug-exposed infants.

Photo of Mitul Sarkar
Team

Great concept- hopefully, it will win here.

Is SVS a surrogate for the cuddling, stroking, etc that a newborn would otherwise experience in the arms of her mother? Or, am I oversimplifying?

Photo of John Konsin
Team

Hi Mitul!
Thanks for the question. Nothing can or should replace human touch and bonding with infants. That being said, SVS has the ability to relax/console infants as measured clinically by recording excess body movements. We've haven't done a direct comparison versus the human touch and recorded mulitple biometrics to compare and contrast. Which would be a great study.

Photo of Mitul Sarkar
Team

Thanks, John.
Regarding your plan to sell the product online for $150ish...
1. Is there data suggesting that SVS (or a different algorithm using your hardware) could improve sleep for *normal* infants? Or, say, normal infants who are *colicky*?
2. Until what age does SVS seem to have a beneficial effect? I'm guessing that at some developmental stage of the infant/toddler, the stimulation from SVS may not be as useful.

Photo of John Konsin
Team

Mitul, you're welcome. Based on the completed, independent studies and related findings, we believe SVS will be helpful with colic. And by colic, I'm referring to the standard for colic which is when an infant cries for 3 hours, 3 or more days a week for 3 weeks. We'll be doing work in colic and also understanding how we can improve sleep for otherwise healthy infants. Thanks to the CHIME studies, completed over a decade ago, we know that their is variation in infant breathing, heart rate, sleep intervals and other indicators. So, the norm or standard for healthy infant sleep is still unknown.

Regarding to what age does SVS benefit an infant, part of the answer depends on what condition, if any, is present in the infant. Another part of the answer is that it could be up to 6 months. And as you may know a baby box is designed for infants up to 6 months or whenever they can sit up on their own - whichever comes first. Still we want to find out more and that is part of our motivation for pursuing this innovation prize.

Our initial focus is providing a tool for use in the hospital and immediately following discharge for drug-exposed newborns. Our product is not meant to be a permanent, sleep environment for baby during the first six months. We think of it as an option to be used by caregivers when their drug-exposed newborn is frantic, irritable or having extreme difficulty just settling down.

Still, like you, we see and are excited about the possibilities for colic, any infant following a surgical procedure to reduce meds, preemies once they are home and other infant sleep related issues.

Photo of Mitul Sarkar
Team

In the womb, the fetus is probably attuned to the heartbeat of her mother. Do we have reason to suspect that - in a pregnant woman using drugs - the patterns of the maternal heartbeats and their correlation with hormones (adrenaline?) may cause a normal or abnormal entrainment in the fetus?

Photo of John Konsin
Team

Mitul - another great question. Out of my realm. Our focus has and will be on understanding stochastic vibro-tactile stimulation (SVS for short) and how it can benefit infants across many different issues after delivery. The independent research with the technology on drug-exposed infants doesn't address your question. So, you've raised another great topic for discussion and research.

Photo of Ashley Tillman
Team

Hi John Konsin great to have you in the Early Childhood Prize Community! Thanks for sharing about your product.

I'd love to learn a little more about how you envision reaching and supporting the families or care takers using your product. What channels do you use to ensure the device is used correctly? What's your role in education and connecting families and caretakers to additional needed resources? Is this who are the partners or types of partners you have identified to aid in the big picture mission you are working towards?

Looking forward to learning more!

Photo of John Konsin
Team

Hey Ashley! Thanks so much for reaching out about Prapela. Great question. We've thought a lot about making sure the product is used correctly. While we don't have all the answers, I am happy to tell you that the simplicity of the device will help insure correct use. Set up takes a minute. Our box pops up. The insert is placed at the bottom of the box. The line for the plug threads through a small hole in the bottom of the box (below the sleeping surface) and you press the "on" button to start the cycle of stimulation which consoles drug-exposed infants as it helps them breathe. There is no smart phone app, no adjustments to the stimulation, no "data sharing to the cloud" with the product. Once its set up - you turn it on and turn it off when its not in use. Our website, will provide video and educational materials - as you would expect.

However, the best education will come from the hospital/caregiver site and there is a precedent set for this approach.

States, including Colorado, and independent hospitals are already buying baby boxes to promote safe sleep and providing them free to parents at discharge. Typically, the product education is provided by nurses, nurse practitioners and trained volunteers at the hospital.

Likewise, our product is intended to be purchased by the hospital (because it helps providers improve care and lower the cost of treatment), used in the hospital to help the infant through withdrawal and then taken home by mother or family for use to help at home. So, the health care practitioners at the hospital will instruct on the use of the product and Mom will see/understand use of the product based on her experience in the hospital.

Still, I'm sure there are other approaches. However, the pioneering work done with companies, States and hospital staff to promote and improve safe sleep with baby boxes has paved the way for the critical need to improve care and reduce costs for our drug exposed babies and their caregivers.

Would love to hear your suggestions and critique. Do you think we are getting it right? Do you know of partners in education that would be interested in helping these kids and their caregivers? Are we thinking big enough?

Sincerely, John